BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ATW All Track Wire Steerable Guidewire

    Reg #: 1016427 · FEI: 1016427 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    11
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Cordis US Corp.
    Registration Number
    1016427
    FEI Number
    1016427
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    14201 N.W. 60TH AVE.
    City
    Miami Lakes
    State
    FL
    ZIP
    33014
    Country
    US

    Regulatory Submissions

    510(k) Number
    K953760

    Owner / Operator

    Firm Name
    Cordis US Corp.
    Operator Number
    1016427
    Address
    5452 Betsy Ross Drive, --
    City
    Santa Clara
    State
    CA
    Postal Code
    95054
    Country
    US
    Correspondent
    Linda Ruedy

    Products

    Device Name Product Code
    Wire, Guide, Catheter DQX

    Proprietary Names

    ATW All Track Wire Steerable Guidewire Wizdom Extra Support with Markers Steerable Guidewire Wizdom Steerable Guidewire with Markers Wizdom Steerable Guidewire Shinobi Plus Steerable Guidewire Stabilizer Support Guidewire Stabilizer Plus Steerable Guidewire Stabilizer Balance Performance Steerable Guidewire Shinobi Steerable Guidewire Wizdom Extra Support Guidewire

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility